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PCV-20 vaccination for adults during a short febrile illness

Immunogenicity and Safety of the 20-Valent Pneumococcal Conjugate Vaccine (PCV-20) Administered During an Acute Febrile Illness in Adults: a Multicentric Randomized Non-inferiority Trial

Phase 4 Interventional Centre Hospitalier Universitaire de Saint Etienne · NCT06822907

This test sees if giving the PCV-20 pneumococcal vaccine to adults hospitalized with a short, non-severe fever produces the same immune response and safety as giving it after the fever has resolved.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment1052 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorCentre Hospitalier Universitaire de Saint Etienne Academic / other
Drugs / interventionsRituximab, chemotherapy
Locations24 sites (Saint-Etienne, France and 23 other locations)
Trial IDNCT06822907 on ClinicalTrials.gov

What this trial studies

In this randomized Phase 4 trial, adults at increased risk for invasive pneumococcal disease who are hospitalized with a recent non-severe fever are assigned to receive PCV-20 either during the febrile episode (early) or after recovery (delayed). Antibody levels are measured and participants are monitored for vaccine-related adverse events to compare immune response and safety between the two timing strategies. The primary goal is to test non-inferiority of immune responses when vaccination occurs during a transient febrile illness versus delayed vaccination. The trial is conducted at university and regional hospitals in France and enrolls adults with specified comorbidities who have been hospitalized for more than 24 hours.

Who should consider this trial

Good fit: Adults hospitalized for more than 24 hours with a recent measured fever (≥38°C) and at least one medium- or high-risk comorbidity for invasive pneumococcal disease are the intended participants.

Not a fit: People with severe or unstable acute illness, those requiring intensive care, or individuals with contraindications to PCV-20 are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, it could allow safe vaccination during short febrile illnesses and reduce missed opportunities to protect at-risk adults from pneumococcal disease.

How similar studies have performed: Pediatric studies show no safety or efficacy concerns when vaccinating during fever, but adult data are limited, so this approach is relatively untested in adults.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria :

* History of body temperature ≥ 38°C measured at least twice prior to randomization (Randomization must be performed as soon as possible on a febrile patient or 72 hours after apyrexia at the latest)
* Having at least one comorbidity that defines patients as medium or high risk for pneumococcal invasive infection:

  * Medium risk: Cyanogenic congenital heart disease; chronic heart failure; chronic respiratory failure; chronic obstructive pulmonary disease; emphysema; severe asthma under chronic treatment; chronic renal failure; chronic liver disease; diabetes mellitus treated; Osteo-meningeal leak or cochlear implant; Age \> 65 years old.
  * High risk : Hypo or asplenic people; hereditary immunodeficiency syndromes; people living with HIV; solid organ transplanted; People under immunosuppressors (corticosteroids, biotherapy) for an auto-immune or an inflammatory chronic disease; patients with nephrotic syndrome
* Hospitalization for \> 24 hours long
* Social security affiliation
* Signed informed consent

Exclusion criteria :

* Patient unable to give informed consent
* Curators, wardship
* History of previous vaccination with PCV-7 or PCV-13 or PCV-20
* History of PPV-23 in the previous year
* Patient having received another vaccination within one month prior to inclusion or planning another vaccination in the month after inclusion except for Influenza vaccine.
* Patient with history of bone marrow transplantation
* Patient with haematological malignancies
* Patient under chemotherapy for solid tumor or with a history of chemotherapy in the past three months
* Patient treated with Rituximab currently or in the past 6 months
* Patient with Sequential Organ Failure Assessment (qSOFA ) score ≥ 2 at randomization (acute severe febrile illness)
* Patient hospitalized in an Intensive Care Unit
* Pregnancy
* Breastfeeding woman
* Recipients of polyclonal gammaglobulins in the past three months
* Inability to follow the protocol
* Bleeding disorder contra-indicating intramuscular injection according to the investigator
* History of allergy to PCV-20 or vaccine-related components.
* S. pneumoniae infection with laboratory confirmation (blood culture, culture from a sterile site, urinary or Cerebrospinal fluid antigens, sputum culture with \> 10\^7 colony forming unit (CFU)/mL) being the cause of the current hospitalization

Where this trial is running

Saint-Etienne, France and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Febrile IllnessPneumococcal InfectionsvaccinpneumococcalPrevenar 20Acute febrile illnessinfectionsPCV-20
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.